Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRA… (NCT05358249) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Platform Study of JDQ443 in Combinations in Patients With Advanced Solid Tumors Harboring the KRAS G12C Mutation
United States, Belgium, France74 participantsStarted 2022-10-24
Plain-language summary
This is Phase Ib/II, multicenter, open-label adaptive platform study of JDQ443 with select therapies in patients with advanced solid tumors harboring the KRAS G12C mutation.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Dose Escalation:
\- Patients with advanced (metastatic or unresectable) KRAS G12C mutant solid tumors who have received standard of care therapy or are ineligible to receive such therapy.
Phase II:
* Patients with advanced (metastatic or unresectable) KRAS G12C mutant non-small cell lung cancer who have received platinum-based chemotherapy regimen and immune checkpoint inhibitor therapy, unless patient was ineligible to receive such therapy
* Patients with advanced (metastatic or unresectable) KRAS G12C mutant colorectal cancer who have received fluropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, unless patient was ineligible to such therapy.
All patients:
* ECOG performance status of 0 or 1.
* Patients must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines.
Exclusion Criteria:
* Tumors harboring driver mutations that have approved targeted therapies, with the exception of KRAS G12C mutations
* Prior treatment with a KRAS G12C inhibitor is excluded for patients in a subset of groups in Phase II.
* Active brain metastases, including symptomatic brain metastases or known leptomeningeal disease
* Clinically significant cardiac disease or risk factors at screening
* Insufficient bone marrow, hepatic or renal function at screening Other protocol-defined inclusion/exclusion criteria may apply
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose escalation: Incidence and severity of dose limiting toxicities (DLTs) of each combination treatment.
Timeframe: 28 days
2
Dose escalation: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) by treatment
Timeframe: 24 months
3
Dose escalation: Frequency of dose interruptions and reductions, by treatment
Timeframe: 24 months
4
Dose Escalation: Dose intensity by treatment
Timeframe: 24 months
5
PhaseII: Overall Response Rate by Blinded Independent Review Committee (BIRC) per RECIST 1.1